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Last Updated: November 13, 2024

Details for New Drug Application (NDA): 209596


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NDA 209596 describes FLUOCINOLONE ACETONIDE, which is a drug marketed by Allied, Alpharma Us Pharms, Cosette, Fougera Pharms Inc, Invatech, Perrigo New York, Pharmafair, Taro, Usl Pharma, Amneal, Padagis Israel, Quagen, Rising, Sciegen Pharms Inc, Trupharma, Novel Labs Inc, Pharmaderm, Actavis Labs Ut Inc, Bausch And Lomb, Chartwell Rx, Encube Ethicals, Lupin, and Pai Holdings Pharm, and is included in fifty-five NDAs. It is available from fourteen suppliers. Additional details are available on the FLUOCINOLONE ACETONIDE profile page.

The generic ingredient in FLUOCINOLONE ACETONIDE is fluocinolone acetonide. There are twelve drug master file entries for this compound. Twenty-two suppliers are listed for this compound. Additional details are available on the fluocinolone acetonide profile page.
Summary for 209596
Tradename:FLUOCINOLONE ACETONIDE
Applicant:Chartwell Rx
Ingredient:fluocinolone acetonide
Patents:0
Pharmacology for NDA: 209596
Medical Subject Heading (MeSH) Categories for 209596
Suppliers and Packaging for NDA: 209596
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FLUOCINOLONE ACETONIDE fluocinolone acetonide SOLUTION;TOPICAL 209596 ANDA Glasshouse Pharmaceuticals Limited Canada 71428-002 71428-002-60 1 BOTTLE in 1 CARTON (71428-002-60) / 60 mL in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;TOPICALStrength0.01%
Approval Date:Dec 26, 2017TE:ATRLD:No

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